Status:
COMPLETED
Precision Nutrition Strategies for Improving the Quality of Life of Pre-senior and Senior Populations
Lead Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Conditions:
Overweight or Obesity
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief Summary
The number and proportion of people aged 60 years old and over is increasing worldwide. Ageing is characterized by a progressive loss of physiological integrity, leading to impaired function and incre...
Detailed Description
This study is designed as a 12-week, randomized parallel intervention trial, with two arms: 1) Control group, who follows a control diet based on the current dietary guidelines of the Spanish Society ...
Eligibility Criteria
Inclusion
- Men and women aged 50-80 years
- BMI \>27 kg/m2
- One or more of the following risk factors:
- Glucose ≥100 to ≤125 mg/dL or type 2 diabetes (independently of antidiabetic medication)
- Hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg or under antihypertensive medication)
- LDL-cholesterol ≥160 mg/dL independently of lipid-lowering therapy
- HDL-cholesterol ≤40 mg/dL (men)/≤50 mg/dL (women), independently of lipid-lowering therapy
- Triglycerides ≥160 mg/dL independently of lipid-lowering therapy
- Waist Circumference ˃95 cm (men)/\>82 cm (women), independently of lipid-lowering therapy
- Sedentary behavior (AHA)\*
Exclusion
- Relevant functional or structural digestive abnormalities (malformations, angiodysplasia, active peptic ulcers, chronic inflammatory diseases, or malabsorption)
- Endocrine disorders (hyperthyroidism or uncontrolled hypothyroidism)
- Undergone surgical interventions with permanent sequelae (gastroduodenostomy)
- Pharmacological treatments with immunosuppressants, cytotoxic agents, systemic corticosteroids, or other drugs that could potentially cause hepatic steatosis or alteration of liver tests
- Active cancer in the last five years or under therapy
- Weight loss ≥3 kg in the last three months
- Instable drug therapy in the last three months
- Severe psychiatric disorders
- No autonomy
- Inability to follow the diet (food allergies, intolerances)
- Difficulties to follow scheduled visits
- AHA Recommendations for Physical Activity in Adults: at least 150 minutes per week of moderate-intensity aerobic activity or 75 minutes per week of vigorous aerobic activity, or a combination of both, preferably spread throughout the week.
Key Trial Info
Start Date :
October 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2020
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT04786925
Start Date
October 16 2018
End Date
December 23 2020
Last Update
March 8 2021
Active Locations (1)
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1
Centre for Nutrition Research, University of Navarra
Pamplona, Navarre, Spain, 31008